Kagoshima Collaborate Trial in Metabolic Syndrome (KACT Study)

Effects of Valsartan on Metabolic Syndrome in Patients With Hypertension

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00790946

Acronym

KACT

Enrollment

250

Registered

2008-11-14

Start date

2006-06-30

Completion date

2009-12-31

Last updated

2010-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Obesity

Keywords

valsartan, Metabolic syndrome

Brief summary

The purpose of this study is to consider the following points in patients with hypertension who complicated by metabolic syndrome for Valsartan basis treatment and an existing, standard treatment. * Blood pressure control * Changing of adiponectin and plasminogen activator inhibitor-1 * Influence metabolizing and cardiac function, etc.

Detailed description

The primary endpoints are: * blood pressure control * Adiponectin and plasma type1 plasminogen active inhibitor The secondary endpoints are * HOMA-IR * HbA1c * TNF-α * IL-6 * Plasma B-type natriuretic peptide * LVMI * E/A ratio * Tei-index * Apo-J

Interventions

DRUGValsartan

Valsartan 80 to 160 mg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Out patients with hypertension male and female * Systolic blood pressure (SBP)≧140mmHg and/or diastolic blood pressure (DBP)≧90 mmHg * Waist Surrounding diameter male≧85cm female≧90cm * Patient who is treating either high triglyceride,low HDL,or diabetes mellitus * Patient who is untreatment high triglyceride blood syndrome and low HDL blood syndrome,diabetes mellitus is triglceride≧150mg/dl and/or HDL cholesterol \< 40 mg/dl or fasting blood glucose ≧110 mg/dl * Untreated patients with hypertension,or patients is treated with antihypertensive agents except for ACE-I and ARB

Exclusion criteria

* Patient who is using ACE-I and ARB * Serum creatinine ≧ 3 mg/dl * Liver impairment * History of allergy to valsartan * Pregnant women * Judgment by the physician that participation was unwise on the basis of patient characteristics and drug safety

Design outcomes

Primary

Measure	Time frame
Blood Pressure, Adiponectin and PAI-1 concentration	1 year

Secondary

Measure	Time frame
HbA1c	1 year
TNF-α	１ year
IL-6	1 year
BNP	1 year
HOMA-IR	1 year
E/A ratio	1 year
Tei-index	1 year
Apo-J	1 year
LVMI	1 year

Countries

Japan

Contacts

Primary ContactChuwa Tei, MD, PhD

tei@m.kufm.kagoshima-u.ac.jp

Backup ContactMasaaki Miyata, MD, PhD

miyatam@m3.kufm.kagoshima-u.ac.jp＋81-99-275-5318

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026